Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141154
First received: August 30, 2005
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.


Condition Intervention Phase
Low Back Pain
Drug: Celecoxib
Drug: Placebo
Drug: Loxoprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's pain assessment (VAS: Visual Analogue Scale)

Secondary Outcome Measures:
  • Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)

Enrollment: 1234
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
  • Patients who have had low back pain for at least two weeks

Exclusion Criteria:

  • Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141154

Locations
Japan
Pfizer Investigational Site
Funabashi, Chiba, Japan, 273-0035
Pfizer Investigational Site
Funabashi-shi, Chiba, Japan
Pfizer Investigational Site
Matsudo-shi, Chiba, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan
Pfizer Investigational Site
Chitose, Hokkaido, Japan, 066-0026
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site
Katougun, Hyogo, Japan, 673-1462
Pfizer Investigational Site
Kobe, Hyogo, Japan, 650 0004
Pfizer Investigational Site
Nishinomiya, Hyogo, Japan, 662-0838
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Yokohama-shi, Kanagawa, Japan
Pfizer Investigational Site
Hatogaya-shi, Saitama, Japan
Pfizer Investigational Site
Kumagaya-shi, Saitama, Japan, 3600012
Pfizer Investigational Site
Kumagayashi, Saitama, Japan, 3600854
Pfizer Investigational Site
Minamisaitama-gun, Saitama, Japan
Pfizer Investigational Site
Saitama-shi, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
,Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Adachi-Ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyou-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Itabashi-ku, Tokyo, Japan
Pfizer Investigational Site
Koito-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-Ku, Tokyo, Japan
Pfizer Investigational Site
Nakano-ku, Tokyo, Japan
Pfizer Investigational Site
Nerima-ku, Tokyo, Japan
Pfizer Investigational Site
Ota-Ku, Tokyo, Japan, 145-0066
Pfizer Investigational Site
Ota-Ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shibuya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-ku, Tokyo, Japan, 140-0001
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Suginami-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan, 131-0043
Pfizer Investigational Site
Toyoshima-ku, Tokyo, Japan
Pfizer Investigational Site
Chiba, Japan, 266-0031
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Fukuoka, Japan, 810-0004
Pfizer Investigational Site
Tokyo, Japan, 140-0011
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00141154     History of Changes
Other Study ID Numbers: A3191174
Study First Received: August 30, 2005
Last Updated: May 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Celecoxib
Loxoprofen
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014